The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Guide, Wire, Angiographic.
| Device ID | K850827 |
| 510k Number | K850827 |
| Device Name: | GUIDE, WIRE, ANGIOGRAPHIC |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jim Klosterman |
| Correspondent | Jim Klosterman LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734054871 | K850827 | 000 |
| 15414734054857 | K850827 | 000 |
| 15414734054833 | K850827 | 000 |
| 15414734054819 | K850827 | 000 |
| 15414734054796 | K850827 | 000 |